Evidence map›Paper›PMID 29654415›Full record

Trial reportBreast cancer research and treatment2018

Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2.

Sunil Verma, Joyce O'Shaughnessy, Howard A Burris, Mario Campone, Emilio Alba, David Chandiwana, Anand A Dalal, Santosh Sutradhar, Mauricio Monaco, Wolfgang Janni

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01958021 (A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease), which is not on this map. Cited by 44 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 6 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01958021 phase3completednot on this map

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2023Enrolled668ConditionsAdvanced, Metastatic Breast CancerArmsRibociclib, Letrozole, Placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 6 syntheses or guidelines pooled it, 92 citations in OpenAlex.

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  6. Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

Sunil VermaDepartment of Oncology, Cumming School of Medicine, Tom Baker Cancer Centre, University of Calgary, 1331 29th Street NW, Calgary, AB, T2N 4N2, Canada. DrSunil.Verma@ahs.ca.ORCID http://orcid.org/0000-0002-8807-6215
Joyce O'ShaughnessyTexas Oncology-Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center, and The US Oncology Network, 3410 Worth Street, Suite 400, Dallas, TX, 75246, USA.
Howard A BurrisDrug Development, Sarah Cannon Research Institute, 250 25th Avenue North, Suite 100, Nashville, TN, 37203, USA.
Mario CamponeMedical Oncology, Institut de Cancérologie de l'Ouest/René Gauducheau Centre de Recherche en Cancérologie, Boulevard Jacques Monod, Nantes, 44805, Saint-Herblain, France.
Emilio AlbaMedical Oncology Unit, Hospital Universitario Virgen de la Victoria, IBIMA, 29010, Málaga, Spain.
David ChandiwanaNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936-1080, USA.
Anand A DalalNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936-1080, USA.
Santosh SutradharNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936-1080, USA.
Mauricio MonacoNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936-1080, USA.
Wolfgang JanniDepartment of Gynecology, Universitätsklinikum Ulm, Prittwitzstraße 43, 89075, Ulm, Germany.
Hospital Clínico Universitario Virgen de la Victoria · ESInstitut de Cancérologie de l'Ouest · FRSarah Cannon · USTexas Oncology · USUniversity Hospital Ulm · DEUniversity of Calgary · CA

Funding

Novartis Pharmaceuticals Corporation n/a
6 · The paper itself

Abstract

purposeEvaluate patient-reported outcomes (PROs) for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer treated with first-line ribociclib plus letrozole.

methodsIn the phase III MONALEESA-2 study (NCT01958021), 668 patients were randomized 1:1 to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole. PROs were assessed using the European Organisation for Research and Treatment of Cancer core quality-of-life (EORTC QLQ-C30) and breast cancer-specific (EORTC QLQ-BR23) questionnaires. Changes from baseline and time to deterioration in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively. Exploratory analysis of area-under-the-curve for change from baseline in pain score (AUC-pain) was performed.

resultsOn-treatment HRQoL scores were consistently maintained from baseline and were similar between arms. A clinically meaningful (> 5 points) reduction in pain score was observed as early as Week 8 and was maintained up to Cycle 15 in the ribociclib arm. A statistically significant increase in mean AUC-pain was also observed in the ribociclib arm. Scores for all other EORTC QLQ-C30 and EORTC QLQ-BR23 domains were maintained from baseline and were similar between arms.

conclusionsHRQoL was consistently maintained from baseline in postmenopausal women with HR+, HER2- advanced breast cancer receiving ribociclib plus letrozole and was similar to that observed in the placebo plus letrozole arm. Together with the improved clinical efficacy and manageable safety profile, these PRO results provide additional support for the benefit of ribociclib plus letrozole in this patient population.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleHumansLetrozoleMiddle AgedPostmenopausePurinesReceptors, EstrogenReceptors, ProgesteroneAminopyridinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozolePurinesReceptors, EstrogenReceptors, ProgesteroneribociclibAdvanced breast cancerCDK4/6 inhibitorEndocrine therapyHealth-related quality of lifeHormone receptor-positiveRibociclib

Identifiers

PMID29654415
PMCPMC6022531
OpenAlexW2798042703

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.